Model Number 778726 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Urinary Tract Infection (2120)
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Event Date 05/22/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced hematuria prior to the device placement, infection, urinary symptoms complications were directly attributable to the device and antibiotics was needed in relation to ureteral stent without guidewire.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Manufacturer Narrative
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The reported event was inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause was material selection.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.Submerge stent in sterile water to activate the coating.Insert the cystoscope then pass the guidewire.Through the scope until the tip is in the renal pelvis.Move the pigtail straightener over the proximal end (kidney coil end) of the ureteral stent allowing easier insertion onto the guidewire.Remove pigtail straightener once the stent is secure on the guidewire.Pass the stent over the guidewire through the cystoscope by using the push catheter for proper placement.Watch the distal end (bladder coil end) of the stent or the radiopaque, proximal end of the pusher.Stop advancing when the stent¿s distal end marker reaches the ureterovesical junction (uvj).(see below for proper placement directions on the multi-length ureteral stent.) withdraw the guidewire slowly.The stent will form a pigtail automatically.Carefully remove the push catheter." h11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: the device was not returned.
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Event Description
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It was reported that the patient experienced hematuria prior to the device placement, infection, urinary symptoms complications were directly attributable to the device and antibiotics was needed in relation to ureteral stent without guidewire.
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Search Alerts/Recalls
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